Job Openings >> Quality Manager
Quality Manager
Title:Quality Manager
Location:Buffalo, NY
Nissha Medical Technologies is looking for a Quality Manager to join our facility! In this role, the Quality Manager will report to the Director of Quality and will be responsible for implementation and management of the Quality Management System, establishment and tracking of Quality KPIs, for developing short and long-range Quality Department plans and budgets.

If you're looking to join a growing company, we encourage you to apply!

Further Essential Functions Include:
  • Follow Employee guidelines and Quality System Regulations as defined by Nissha Medical Technologies practices, policies and Standard Operating Procedures to ensure that customer requirements and industry standards and or regulations are met.
  • Demonstrates knowledge and acts in accordance with NMT’s Employee Guidelines and applicable quality standards as outlined in NMT’s Quality Manual.
  • Responsible for implementation and management of the Quality Management System
  • Responsible for the establishment and tracking of Quality KPIs.
  • Develop short and long-range Quality Department plans and budgets.
  • Develop and implement standards, methods, and procedures for process validations, equipment calibration and contamination control.
  • Implement and ensure execution of all inspection activities.
  • Assure that all work performed conforms to 21 CFR 820, EU MDR 2017/245, Health Canada SOR/98-282 and ISO 13485 standards and is conducted in accordance with cGMP regulations on the production floor.
  • Write, revise and review Standard Operating Procedures (SOPs), validation protocols and test plans and protocols that are pertinent to company product quality.
  • Implement performance standards for testing of equipment and scheduling of calibrations.
  • Oversee the resolution of customers’ technical issues and complaints.
  • Schedule and conduct corporate Management Reviews.
  • Identify and implement process improvements.
  • Address and implement corrective and preventive actions
  • Manage the scheduling and execution of internal and external audits.
  • Act as the primary company interface with the FDA and ISO 13485 Registrar.
  • Responsible for selection, supervision, and performance management of department employees.
  • Participate in staff management training and effectively manage employees in compliance with federal and state employment laws and regulations.
  • Interview, hire, and train new department employees.
  • Conduct timely performance reviews, establish clear goals, and support learning opportunities for job skills and career growth.
  • Abides by all safety and security rules set forth by the company and regulatory agencies
Qualifications & Experience
  • Bachelor’s degree in Business, Science, or Engineering required. Master’s degree preferred.
  • CQM Certification desired.
  • Three years’ experience required working in an ISO 13485 and FDA- regulated medical device environment.
  • Experience in process improvement methods desired.
  • Experience reading and understanding regulations, standards, drawings and procedures.
  • Supervisory experience strongly preferred.
Nissha Medical Technologies is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Nissha Medical Technologies will provide reasonable accommodations for qualified individuals with disabilities.
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Nissha Medical Technologies
400 Exchange Street
Buffalo, NY 14204
Nissha Medical Technologies is the medical devices business unit and wholly owned subsidiary of Nissha Co. Ltd., a Japanese publicly held company based in Kyoto, Japan (TSE:7915).
Copyright 2020 Nissha Medical Technologies. All rights Reserved
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